Why it was recalled
CGMP Deviations
Product description
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
Lot numbers, UPCs & expiration codes
Product Codes: C134LC Bulk Lots: 18K055 18M081 19A097 19B024 19C054 19E092 19G094 19J042
Where it was sold
Bulk product was distributed to 3 distributors who may have distributed finished product.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0528-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 26, 2022
- FDA report date
- Feb 16, 2022
- Quantity
- 14,566,510 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ULTRAtab Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0528-2022, exactly as published.
Show all FDA fields
- City
- Highland
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89334
- Address
- 50 Toc Dr
- Code information
- Product Codes: C134LC Bulk Lots: 18K055 18M081 19A097 19B024 19C054 19E092 19G094 19J042
- Postal code
- 12528-1506
- Report date
- Feb 16, 2022
- Product type
- Drugs
- Recall number
- D-0528-2022
- Classification
- Class II
- Recalling firm
- ULTRAtab Laboratories, Inc.
- Product quantity
- 14,566,510 tablets
- Termination date
- Jan 7, 2025
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
- Distribution pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- Recall initiation date
- Jan 26, 2022
- Initial firm notification
- Letter
- Center classification date
- Feb 9, 2022